Dexmedetomidine for Morphine Consumption Reduction (DEXDOR)

Burning Clinical Trial

— DEXDOR  

Official title:

Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904460
• Other study ID #: 2015-03Obs-CHRMT
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: September 13, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.

DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.

Description:

The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use.

DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule.

This study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. It expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• More than 18 years old

• Hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities)

• Having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group

Exclusion Criteria:

• Inability to communicate (language barrier, major cognitive disorders)

• Medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade II or III atrio-ventricular blocks without device, acute brain vascular pathology).

• For the control group, pregnancy is a non-inclusion criterion

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Burning

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz Cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global consumption of opioids (including per anesthesia for bandage or surgery) during the patient care period, expressed as intravenous morphine per day equivalent, indexed on the weight (mg.kg-1.j-1).	mg.kg-1.j-1	day 20	No
Secondary	Tolerance for dexmedetomidine by hemodynamic	mm Hg	day 20	No
Secondary	Efficiency of analgesia	RASS scale	day 20	No